Clinical Trial: A study to evaluate the effects on mood states in middle-aged and elderly women (Japan)

Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060715) titled 'A study to evaluate the effects on mood states in middle-aged and elderly women' on March 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - MIS Co.,Ltd.

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The study will examine the effects of 12 weeks of continuous intake of test foods on mood states in Japanese women aged 40 to 60. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of the test food for 12 weeks Interventions/Control_2 - Intake of the placebo food for 12 weeks

Eligibility: Age-lower limit - 40 years-old = Gender - Female Key inclusion criteria - 1.Japanese women aged 40 to 60 years old at the time of obtaining online consent. 2.Subjects with a T-score of 50 or higher for the Tension-Anxiety (TA) component of the POMS2 Adult Short Version and a total score of 50 or lower on the SMI. 3.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing. Key exclusion criteria - 1.Subjects who have been diagnosed with menopausal symptoms by a physician. 2.Subjects who are taking medication or under medical therapy. 3.Subjects who are under exercise therapy or dietetic therapy. 4.Subjects with current or history of drug dependence or alcohol dependence. 5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep. disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 6.Subjects with irregular life rhythms due to night shifts or shift work. 7.Subjects with extremely irregular lifestyle habits such as eating and sleeping. 8.Subjects who drink excessive alcohol or those at risk of becoming excessive drinkers. 9.Subjects who have an extremely unbalanced diet. 10.Subjects with serious current or previous illnesses such as brain disease, malignancy, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal gland disease, tendon disease, joint contracture, orthopedic disease, or other metabolic diseases. 11.Subjects using health foods, supplements, or medications that affect mental status (anxiety, tension, depression, etc.), the central nervous system, or menopausal symptoms (e.g., anti-anxiety drugs, antidepressants, sleeping pills, first-generation antihistamines, hormone preparations, equol-containing foods, St. John's wort, GABA, theanine, etc.). *These are examples only, and are not limited to these. 12.Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period. 13.Subjects who have collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition. 14.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating. Target Size - 44

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 06 Day Date of IRB - 2026 Year 02 Month 19 Day Anticipated trial start date - 2026 Year 03 Month 18 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069460

Disclaimer: Curated by HT Syndication.